Bioequivalence and Bioavailability Forum

Dear all,

EMA has rcently released Guideline on the requirements for demonstrating Therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) EMA guideline.

It is stated that This guideline replaces "Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev. 1)”

Based on above statement, can we consider this guideline for development of nasal spray for the treatment of seasonal allergic rhinitis?
Can we demonstrate equivalence through in vitro data only (our formulation is not Q1/Q2 similar)?

Looking forwad for expert opinions.

Regards,
QA